vaccine profitability

When we started having kids, we were really tight on money and space, so we had to pick and choose what was most crucial. There are certain no-brainers (like a carseat and a baby carrier). But as we went down the list of all the things we “needed” for our first baby, I realized my parents had never owned a changing table either. They raised three children and changed plenty of diapers without one and we all turned out just fine. And for that matter, my grandparents never owned a changing table, my great-grandparents had never owned a changing and my great-great grandparents… well, you get the idea. So what did people do before changing tables existed?

It’s quite simple. They changed their babies on a floor or table with some sort of changing pad underneath. Throughout thousands and thousands of years of human history, parents didn’t have changing tables and diaper changes went just fine. Ditto on Baby Einstein, Exer-saucers and baby swings. We’ve never owned a baby monitor either. The best way to keep our kids asleep was to put them in a baby carrier, so none of the sleep gadgets have ever been necessary. If you really want any of these items though, more power to you.

I went through a similar process with the flu vaccine. I remember being in college when I first started hearing admonitions to get a flu shot. I never did. I’d had the flu several times and it wasn’t pleasant, but it certainly wasn’t deathly. Maybe elderly people needed one, but I figured I’d probably be fine. I rarely got the flu anyway. And, I reasoned, it’s not like the flu was a serious disease like other diseases that vaccines existed for. (Of course at the time I didn’t know that according to the CDC, the flu shot is actually less effective in elderly and infant populations, the people who are supposed to be at the greatest risk for flu complications. It’s considered most effective in young, healthy people who are least likely to get sick to begin with. Now that’s some good marketing!)

However, I noticed many people who were buying in- literally- to the whole flu shot thing. All of the sudden, an illness that these people had once considered an unpleasant, though not serious, part of life suddenly became a crisis. I saw friends running out to get to flu shots, standing in line, calling their pediatrician’s office repeatedly to see if the flu shot was available. Despite having the flu themselves multiple times and recovering just fine, my friends were now convinced that the flu was a lethal threat to their health and their children’s health. (And even if they became sick after getting a flu shot they still extolled its virtues.) Suddenly something they had never needed before became indispensable.

Of course the same thing is happening for Millennial parents with chickenpox, rotavirus, hepatitis A and hepatitis B. Our generation is doing the same thing our parents did- buying into marketing messages that the diseases we and our grandparents, parents and friends lived through are deadly. It was interesting to hear my parents reasoning on why they felt I needed to have the MMR vaccine even though they had had measles (and mumps and rubella) as children and did just fine. My dad said that truly the measles wasn’t a big deal to anyone when he was a kid, but the doctors said that all babies should get an MMR vaccine now so he figured they knew best. My mother said that no one understood how big a threat measles was at the time. My mother-in-law said that she had to spend a few days at home with the shades drawn and that was simply too awful to allow anyone to endure- even for lifelong immunity. It’s marketing, folks. Convince people that they need something they didn’t think they needed before.

Yes, popular thought is that this type of line of thinking is just a fallacy, but maybe the problem is a sort of reverse fantasy- that measles, mumps, rubella and chickenpox really were serious threats and we live in a world that is so much safer because of pharmaceutical technology. After buying into vaccination, we have to tell ourselves a story about why we need it now.

Proponents of vaccination seem to believe that vaccines are practically a charitable cause for pharmaceutical companies- something that makes very little money but has enormous benefit. It’s all marketing. The same thing that spurs us on to buy the handbag with the designer label, spend huge amounts on a wedding (even though spending large amounts on a wedding is correlated with higher divorce rates), and get that changing table, play mat and baby swing.

Popular Science is an interesting name for a magazine. My understanding has always been that popularity and science don’t necessarily always go hand-in-hand. After all, some of the greatest scientific discoveries and theories have been the most unpopular (like Ignaz Semmelweiss’ research on hand washing, the heliocentric model of the solar system and the theory of evolution). So perhaps you can understand why I raise an eyebrow at a magazine that touts itself as being both scientific and popular. Indeed, it forces a choice on said publication as to where their loyalties lie. Is this publication more interested in being popular or being scientific?

The 2013 article from Popular Science seems to be much more grounded in the “popular” part of its name than the “science”. Written by Francie Diep and titled “How to Argue With The Anti-Vaccine Crazies: A Guide”, this smug little article claims to be a fact-based guide preparing people to refute common anti-vaccine questions and claims. Unfortunately, it looks at popular arguments rather than examining larger issues backed up by credible research. Quotes from the article will appear in italics. You can read the full text (which is far shorter than my analysis here) at the link above. For those of you who remember the infamous Kristen Bell post, this is another one to strap in for as I have gone to great pains to be very thorough in my research and explanation. And as always, I see new connections every time I do one of these grand dissections. I think that is what I love most about writing this blog. So here we go…

CLAIM: Historically, recommended vaccines have been shown to harm children. Why would today’s recommendations be any different?

Yes, some older vaccines had severer side effects than current ones do. I’ll look at two examples, polio and pertussis, which is commonly known as whooping cough.

No one has gotten polio from the newer polio vaccine. Before 2000, pediatricians in the U.S. routinely gave kids a polio vaccine that contained live, attenuated polio virus. Now, American kids get a vaccine with an “inactivated,” or killed, virus. Very rarely, the live virus in the older vaccine could actually revert to its natural state and cause paralysis, a tragic consequence.

Some people in the world still deal with this risk. Live, attenuated polio vaccines are used in some regions where polio is endemic because those who get the live, attenuated vaccine are able to pass on their immunity to others around them, which helps spread immunity more quickly. People are also able to take the live, attenuated vaccine by mouth, instead of in a shot, so it’s quicker and easier to get to people in regions where there are few doctors and nurses. Different countries must judge the risks and benefits of the oral polio vaccine differently; even the U.S. had once judged the live, attenuated vaccine worth the risk, when there was nothing better available.

No one has gotten polio from the newer polio vaccine.

Before the 1990s, kids in the U.S. got a pertussis vaccine with severe potential side effects ranging from fever to fainting fits. Some parents sued vaccine manufacturers, claiming that the shot caused brain damage. Scientists have since determined that the parents’ claim is unproven. U.S. doctors now use a new pertussis vaccine with milder side effects.

Of course, it’s up to everyone to decide individually whether the risks of a medicine outweigh its benefits. Consider the numbers around vaccines, though. Often, something like 1 in 1,000 kids experience moderate side effects such as prolonged crying. For more severe side effects, such as seizures or that rotavirus-caused bowel blockage, the odds go down to one in tens of thousands.

Live, attenuated polio vaccines are used in some regions where polio is endemic because those who get the live, attenuated vaccine are able to pass on their immunity to others around them, which helps spread immunity more quickly. Ah, the fanciful thinking of vaccine proponents attributing all sorts of powers to vaccines that don’t actually exist. It seems Ms. Diep needs a refresher in how vaccines are supposed to work. Vaccines don’t contain “immunity” and they don’t allow people to “pass immunity” to one another- that would defeat the point of mass vaccination and herd immunity which she claims to believe in later in her article. Vaccines contain live or weakened viruses or bacteria that when introduced to the body are supposed to “train” the immune system to recognize and reject the pathogens, supposedly allowing the vaccine recipient to gain immunity without actually suffering the illness. However, while you can’t “pass immunity” through the OPV, the OPV can give an immunodeficient recipient the poliovirus which they may excrete for several years, passing it to others. This is a significant issue with the worldwide eradication of polio, especially in countries with a a high number of HIV infected individuals.

Moving on to DTP vs DTaP… (Again, Diep has not specified which vaccines she is referring to, but judging by the context, it is reasonable to infer that she is referring to the whole-cell live virus diphtheria-tetanus-pertussis shot (DTP) and the inactivated virus diphtheria-tetanus-acellular pertussis shot (DTaP).) “Some parents sued vaccine manufacturers, claiming that the shot caused brain damage. Scientists have since determined that the parents’ claim is unproven. U.S. doctors now use a new pertussis vaccine with milder side effects.”

It sounds like what Diep is referring to hear is the 1980’s controversy over SIDS and DTP, though her account glosses over some pertinent facts. During the 1970’s and 1980’s there were many complaints of death and injury regarding the DTP shot as well as the influenza vaccine and OPV. In 1980, the Office of Technology Assessment was asked by the House Interstate and Foreign Commerce Committee to put together a memorandum on the possibility of a federally funded vaccine injury compensation program. This is a very interesting read and highly informative. The full memorandum can be found here.

“As there is no one ‘at fault’ for these reactions, the injured vaccinee would not be able to successfully sue the manufacturer, doctor, or other defendant in a lawsuit based on negligence; e.g., faulty manufacturing of the vaccine such that it was contaminated, or faulty vaccination such that a nerve was damaged by the injection. However, the courts have developed a legal basis for a potentially successful lawsuit in the doctrines of ‘informed consent’ and (1) the ‘duty to warn.’ l)a person about to be vaccinated should be given a clear explanation of the benefits of vaccination and of the potential side-effects that might occur; and (2) someone in the chain from manufacturer to purchaser (such as a state or federal health agency) to the person who administers the vaccine bears the responsibility to give that explanation.

There has been considerable difficulty in determining what constitutes an adequate warning and whether or not a truly informed decision had been made to be vaccinated (the ultimate test of whether the condition had been satisfied takes place by hindsight in a lawsuit, when the injury has already occurred and the answer is crucial to the success or failure of the lawsuit). Furthermore, ‘informed consent’ and the ‘duty to warn’ imply that the potential vaccinee can refuse the vaccination, but almost all states require that children receive certain vaccinations as a condition of attending school.”

So there are legal grounds for suits that can apply to vaccines because people may not be fully informed of the actual benefits and risks associated with vaccines and because in many cases people are legally required to receive vaccines- and more states are limiting options to refuse for things like school or employment. Along with these legal grounds for suit, people can and have successfully sued in court for vaccine injury.

“The National Childhood Vaccine Injury Act of 1986 (PDF), as amended, created the National Vaccine Injury Compensation Program (VICP), a no-fault alternative to the traditional tort system. It provides compensation to people found to be injured by certain vaccines. Even in cases in which such a finding is not made, petitioners may receive compensation through a settlement.

The VICP was established after lawsuits against vaccine manufacturers and healthcare providers threatened to cause vaccine shortages and reduce vaccination rates. The Program began accepting petitions (also called claims) in 1988.”

Now back to DTP specifically. As of 1988, 3,982 petitions have been filed about the DTP vaccine. 3,286 petitions were for injury and 696 were for deaths. 1,273 were compensated and 2,706 were dismissed. Compensation does not mean an admission of guilt that the vaccine caused the injury, often it can mean simply that a negotiated settlement was reached, often with a desire to avoid the cost and expense of litigating a case. The government just pays people to make the problem of vaccine lawsuits go away and is doing it now more than ever. DTP still holds the VICP record for most claims filed, though influenza vaccines are catching up and slightly more compensations have been made for influenza vaccines than DTP at this point.

On to the issue that scientists have now proven parents’ claims of death and injury to be unproven. In the late 1980’s several studies started coming out in response to claims that DTP caused SIDS. Dr. James Cherry of UCLA was at the forefront of the movement to discredit a relationship between the two and has since participated in many other studies and works advocating the further need for use and continued to development of the pertussis vaccine. There is one possible problem with Dr. Cherry though. He has a substantial conflict of interest because he has served as a consultant for GlaxoKlineSmith Biologicals and Sanofi Pasteur for pertussis vaccines. Another article he worked on contains this financial disclosure: “Dr. Cherry has given talks in programs supported directly and through program grants by Sanofipasteur and GlaxoSmithKline. Dr Cherry has consulted about pertussis vaccines with Sanofipasteur and GlaxoSmithKline.” Interestingly enough, Andrew Wakefield has been roundly condemned for conflicts of interest, though that argument has not been seen as a legitimate reason for questioning the research of scientists like Dr. Cherry. As for the infants who die from pertussis, the numbers are not in dispute, but the ability of the pertussis vaccine to actually prevent the spread of the disease is highly debatable and will be addressed later on herein.

On to measles. Measles has become kind of a “boogeyman” that lurks in the closet. The reality is that before the measles vaccine was introduced, people were probably less afraid of it than they are now and that we have far more deadly threats than measles in the 21st century that don’t get nearly as much media attention. The 1953 report from the office of Vital Statistics shows that measles deaths were approximately 13 per 100,000 in 1918 for an estimated population of 103, 208,000. But by by 1950, measles deaths had fallen far below 1 in 100,000. This report states that while infectious diseases like diphtheria, measles and whooping cough were responsible for 242.6 per 100,000 deaths in children under 15 in the early twentieth century, by 1950 these diseases combined accounted for only 5 deaths per 100,000 for children under 15. Take note that the measles vaccine was not introduced until 1963. (MMR became available in 1971 and the DTP vaccine started mass usage in 1948.) Ironically enough, this report is glowing with optimism about the state of health in America, while we perceive this to be a time of rampant disease and death.

Better reporting could be debatable (again we’ll get to non-classical measles in a minute), though the emergence of HIV certainly added a new variable to the measles equation that had not been seen before. The other interesting thing is the higher proportion of cases among children under 5 and adults. If you check out Table 2 of this study, it will show you the rates of complications for measles cases between 1987 and 2000 by age group. As you can see, school age children (the group most likely to get measles before routine measles vaccination) are actually the least likely to suffer complications. However, children under 5 and adults have a greater risk for complications, with adults over 30 having the greatest risk for severe complications like encephalitis and death. In our haste to prevent the spread of measles in our schools, we have overlooked the fact that school age children as a group have the fewest complications for measles and if they do contract the virus they gain lifelong immunity. Instead, when the measles vaccination does grant temporary immunity to children, it can leave them open to measles as adults when they are more prone to serious complications.

CLAIM: It is dangerous for little babies to get so many vaccines at one time. The immune system can get overwhelmed.

Babies really do get a lot of vaccines at once. Their first round alone includes six shots. And the list of recommended childhood vaccines has grown in recent decades, as researchers have developed more and more immunizations.

States with lenient policies about immunization exemptions had 90 percent more whooping cough cases than stricter states.However, numerous studieshavefoundnolink between getting the recommended schedule of vaccines and getting other diseases later in childhood. There’s no credible scientific evidence that vaccines are able to “overload” babies’ immune systems. Though immature, babies’ systems are prepared to handle vaccines. They already handle numerous viruses and bacteria all around them in everyday life.

The U.S. Centers for Disease Control and Prevention recommend vaccines at very young ages because that’s when kids are the most vulnerable, as some of the natural immunization they got from breastfeeding fades.

“States with lenient policies about immunization exemptions had 90 percent more whooping cough cases than stricter states.” Now this is an interesting claim since the pertussis vaccine has had a number of problems with efficacy.

In 2002, vaccine proponent Arthur Allen wrote an article titled Bucking the Herd about the importance of vaccination to prevent the outbreak of disease. In his article, Mr. Allen stated that pertussis has become endemic in Boulder, Colorado and blames it on the high number of unvaccinated children there. He undermines his own argument, though, when he states “Although unvaccinated children are six times as likely as vaccinated children to get whooping cough during an outbreak, about half the cases in Colorado have involved vaccinated children…” If half the children in Colorado with pertussis have been vaccinated, then obviously they are not six times less likely to contract the disease. If vaccines actually are as effective as public health and medical authorities claim they are, then herd immunity shouldn’t make a difference in protecting vaccinated individuals. If vaccination rates drop, then vaccinated individuals should still be protected against the disease while unvaccinated individuals succumb to it. If vaccines can only work in a “sterile” environment where the pathogen is no longer present, then vaccines would be incapable of eradicating diseases.

However, numerous studieshavefoundnolink between getting the recommended schedule of vaccines and getting other diseases later in childhood. There’s no credible scientific evidence that vaccines are able to “overload” babies’ immune systems.

Now there were a couple of interesting things here. The study about how there are no cognitive delays in fully vaccinated versus children who do not meet the definition of fully vaccinated has a couple of questionable things about it. First of all is the financial disclosure : “Drs Smith and Woods are or have been unfunded subinvestigators for cross-coverage purposes on vaccine clinical trials for which their colleagues receive funding from Wyeth, Sanofi Pasteur, GSK, MedImmune, and Novartis; and Dr Woods has received honoraria for speaking engagements from Merck, Sanofi Pasteur, Pfizer, and MedImmune and has received research funding from Wyeth and Sanofi Pasteur.” So again, it’s something to consider. If we’re uncomfortable accepting research about autism and vaccination from someone who has financial conflicts of interest, in the nature of scientific inquiry, we should be willing to apply a similar standard to research that supports vaccination.

Another potential problem with this study is what is referred to as “confounding” in statistics. If you read the full text of the study, it states: “Children with later vaccine receipt had lower family household incomes in both analyses, although all groups averaged well above the poverty level. They also had lower percentages of mothers with college degrees. Finally, there were greater proportions of male children and single-parent households in the less timely groups. These differences did not reach statistical significance in the primary analyses of timely versus untimely receipt but did in the secondary analyses of most timely versus least timely receipt.” (Quick note: the term “statistical significance” means that after doing a set of calculations you can determine whether or not a particular result is due to chance or “fluke”. If something is determined to be “statistically significant”, it means that the result is not due to chance. If a result does not reach statistical significance, it means that the result could be due to chance. This is a simplified version of the definition that doesn’t get into things like p values and the value of alpha, but for the purposes of understanding a study, it’s sufficient.)

So when the researchers in this study say their results did not reach statistical significance the first time, it means that the results did not indicate a strong correlation between vaccination status and cognitive function in their first analysis. But they ran a second analysis and say their results did show a strong correlation. (Which would certainly be fortunate for their interests in performing this study and getting the desired outcome.) If you take a look at Table 2, you can see that the sample sizes (value denoted as n) are different on the primary vs. secondary analysis. In the secondary analysis, the researchers compared only children classified as “most timely” and those classified as “least timely”. In certain parts of the study, the authors state that they did control for factors such as maternal education and IQ, computer experience, etc. , the multivariable analysis, but when comparing the most and least timely, there could be problems with confounding since the researchers acknowledge that there were more children in the least timely category who came from single parent homes with mothers who had lower education levels and lower incomes while more children in the most timely category had higher incomes and two parent homes with better educated parents, so if they really did just compare the most and least timely, socioeconomic factors could be responsible for the outcome in the secondary analysis. Thus, the term confounding.

Furthermore, since this study was published new vaccines and doses have been added to the American vaccine schedule so the results are less relevant with the current schedule. I wouldn’t take this study as conclusive proof that vaccination will affect your child’s cognitive abilities one way or the other. There may have been some “massaging” of the data that in my mind makes it less reliable as a source. Now that I’ve flogged that one to death, let’s take on just one more of the safety studies cited in this article…

The 2001 study by Destefano, Mullooly, Okoro, et. al. in Pediatricsconcerns the timing of vaccine as a possible risk factor for developing type 1 diabetes mellitus (formerly known as juvenile diabetes). The article links off to an abstract of this study, but with a little digging, you can find the full text. The authors claim to be looking at the hepatitis B and Haemophilus influenzae B vaccines specifically, though the study gives results for several other vaccines including whole cell and acellular pertussis vaccines, MMR and varicella. There are a couple of interesting things going on with this study. One has to do with cases and controls. This is a case-control study, meaning that the study compares people with the disease or outcome (cases) with those who do not have the disease or outcome (controls or referent). This study is a little hazy about what they actually qualify as a control. In the case of Hepatitis B vaccination, those who had never been vaccinated for Hepatitis B were used as the referent. (We can assume that all the children had received at least some vaccines as the study later states that all the cases and controls had received the MMR vaccine.) The referent switches on the data for Hib vaccination to children who had received 3 doses by 8 months plus 1 dose at 12–18 months. Referents are not specified for either of the pertussis vaccines, MMR or varicella. (It seems it would be difficult to come up with a referent for MMR since all the children in this study had received the shot.) A big weakness that I see in this study is that half of the cases were born between 1988 and 1990, meaning that they were on a vaccine schedule with fewer vaccines than the children in the study who were born between 1991-1997.

Nevertheless, thimerosal no longer appears in any vaccines except influenza because an infant receiving the recommended schedule of old vaccines would get a higher-than-recommended dose of mercury, which is toxic in high levels.

The Children’s Hospital of Philadelphia has more information on the ingredients in vaccines. They are not dangerous.

Now getting into the actual link cited here, the page was written by Dr. Paul Offit. He is one of the developers of the Rotateq vaccine and has gotten a great deal of media attention lately from news articles applauding his hard line stance against parents who want to selective/delay vaccinate or not vaccinate at all and from his involvement with the PBS documentary “The War on Vaccines”. Despite his claims that alternative medicine and figures like Dr. Sears take advantage of parents’ feelings and media attention, Dr. Offit receives the same kind of attention and it has made him (and the Rotateq vaccine) more and more prominent. Frankly, I don’t find him a credible authority on vaccines because of the following:

A tendency to overdramatize- For a sampling of Dr. Offit’s tactics, take a look at this interview PBS did with him for the ever so diplomatically named documentary, “The War on Vaccines”. You will actually read him calling not vaccinating for measles as playing Russian roulette. We’re talking about a disease with a fraction of the morbidity and mortality of cancer in the United States. For comparison, recall that the CDC states that “In the United States, measles caused 450 reported deaths and 4,000 cases of encephalitis annually before measles vaccine became available in the mid-1960s.” Here are the estimates of numbers for cancer in the United States for 2016 from the American Cancer Society:

“About 1,685,210 new cancer cases are expected to be diagnosed in 2016 and… about 595,690 Americans are expected to die of cancer in 2016, which translates to about 1,630 people per day.” (And by the way, heart disease causes even more deaths in the United States annually than cancer does.) And here is Dr. Offit trying to convince us that measles will be a serious health impact?! But remember it’s extremely important for his Rotateq vaccine and his position as vaccine developer and expert that parents and pediatricians not question the current vaccine schedule and believe that death and destruction will follow from not vaccinating. If parents start questioning which vaccines are necessary, rotavirus will probably be one of the first on the chopping block because it’s extremely rare for a child in a developed country to actually die from the disease and all of us grew up just fine without it. And if we start questioning that, then we start asking about why we need to vaccinate for chickenpox (which was a mild illness when we were growing up and not a cause for concern), and then we’ll start questioning measles and mumps (which were considered mild illnesses when our parents were growing up and not a cause for concern). Pretty soon, the entire vaccine industry would be losing a lot of money. So yes, characterizing measles as “Russian roulette” is not an accurate representation and instead sells parents and healthcare providers an inaccurate picture of risks that favors Dr. Offit’s interests.

Bigotry- If you’re on the right side of the debate (the side that believes vaccines are the answer and the more the better), you are rational and well-informed and without any competing interests. If you don’t vaccinate or selective/delay vaccinate or support such decisions, you are selfish, ignorant and have ulterior motives, based on attention or profit. He claims it doesn’t matter that he has a profit interest in vaccines, because his vaccine works. Dr. Offit claims in his interview that a study comparing parents who vaccinate and don’t vaccinate would be fundamentally flawed because parents who vaccinate and those don’t are so fundamentally different. Parent who don’t vaccinate, he claims would be less likely to think their child has a problem because they think that not vaccinating will prevent developmental problems and other health problems. He does not think that parents who vaccinate could be subject to the same prejudice in reverse. PBS should be ashamed to be disseminating such bigotry, but they don’t seem to be able to pull their heads out and see this sort of “snow job” for the prejudice it is, they’re simply too set in the mindset that we must vaccinate or die to see anything else. But remember folks, when people were protesting on the steps of Little Rock High School about integration, they weren’t doing it because they considered themselves ignorant, prejudiced, bigoted, uninformed or hateful. They were doing it because they believed integration to be a genuine threat to their children’s health and safety and could point to research showing that people from other ethnicities were inferior to back up their stance. That’s the great thing about bigotry. It’s easy to see it in other decades and places, but not in our time and place.

Can he even get his facts straight? I was not impressed with his scare story of a pertussis outbreak in Delaware and I’m a little suspicious of whether he is even presenting accurate facts on this incident. He says that in 2006 there was an outbreak of pertussis in Delaware that was reported in the CDC’s Morbidity and Mortality Weekly Report and that most of the incidents of pertussis were in school age children ages 5-9. I have not been able to find a MMWR bulletin that meets this particular description. However, I did find one that detailed a pertussis outbreak in Kent County, Delaware in an Amish community during September 2004 through February 2005. This was published on August 4, 2006. This report details that most of the cases were preschool age children. (And in fact the charts published with this report showed that the breakdown by age group of pertussis cases in the Amish community differs substantially from the United States as a whole. The majority of the pertussis cases in the United States actually occur in adults with children ages 11-14 second. If this is the outbreak of pertussis he was referring to, there is something very ironic about it. Of the 123 patients ages 6 months to 5 years in the interviewed Amish households, almost one in four (24%) had records of receiving three or more doses of DTP or DTaP. (And another 5% had records of receiving 1 or 2 doses of DTP or DTaP.) The rate of vaccination for the interviewed households where clinical pertussis had been discovered was 45% not vaccinating any children, 42% vaccinating at least some children and 14% declined to give information about vaccination status. So out of the 40 households with at least one clinical pertussis case reporting at least some level of vaccination, 35 cases of pertussis were present. And out of 43 households with at least one pertussis case reporting no vaccination, 88 cases were present. But then of course, this may not account for vaccinated cases that do not meet the clinical definition, as noted above.

And the things he won’t tell you about his Rotateq vaccine from the Clinical Microbiology Reviews…

Rotateq: “Diarrhea and vomiting occurred more frequently among vaccine recipients than among placebo recipients. The efficacy of RotaTeq was evaluated in two phase III trials (10, 85). In these trials, the efficacy of RotaTeq against rotavirus gastroenteritis of any severity after completion of a three-dose regimen was 74%, and that against severe rotavirus gastroenteritis was 98%. RotaTeq also proved to be strongly efficacious in preventing rotavirus gastroenteritis of any severity caused by the predominant G1 serotype (75% efficacy) and the G2 serotype (63% efficacy). There was a trend toward efficacy for the remaining serotypes, but patient numbers were too small to show statistical significance (83% efficacy for G3, 48% efficacy for G4, and 65% efficacy for G9). The efficacy of RotaTeq in reducing the number of office visits for rotavirus gastroenteritis and in reducing the number of emergency department visits and hospitalizations for rotavirus gastroenteritis was evaluated in a large study. (85). The efficacy of RotaTeq in reducing the number of office visits for rotavirus gastroenteritis among 5,673 subjects and in reducing the number of emergency department visits and hospitalizations for rotavirus gastroenteritis among 68,038 subjects over the first 2 years of life was evaluated. RotaTeq reduced the incidence of office visits by 86%, emergency department visits by 94%, and hospitalizations for rotavirus gastroenteritis by 96%. Efficacy against all gastroenteritis hospitalizations of any etiology was 59%. The efficacy of RotaTeq in the second rotavirus season after immunization was 63% against rotavirus gastroenteritis of any severity and 88% against severe rotavirus gastroenteritis.”

In other words:

Children who receive the Rotateq vaccine may be sick with diarrhea and vomiting more frequently than those who do not.

The Rotateq vaccine protects against particular strains of rotavirus. Its efficacy against other strains has not been determined with certainty.

Efficacy of Rotateq against all rotavirus infections of any severity is below 80%- nowhere near enough to establish herd immunity- a concept that Dr. Offit actively promotes.

The efficacy of Rotateq diminishes over time.

So, no, I’m not too confident in anything Dr. Offit has to say about vaccination.

Aside from Dr. Offit, I personally think there are some interesting issues with vaccine excipients that still are worth studying beyond thimerosal. For example:

Potassium dibasic phosphate is an excipient in MMR Pro Quad. PDP is known to cause tumors and damage to the kidneys. (From the cited study: “We have also recently demonstrated the promoting effect of PDP on early-stage renal carcinogenesis…”) Children receive two doses of the MMR vaccine during the first five years of their life, the same time frame that most cases of Wilms tumor occur.

Most vaccines are administered through intramuscular injection and contain carcinogens. This should be investigated as a contributing factor to rhabdomysarcoma. Rhabdomysarcoma is cancer of the skeletal muscles, where most vaccinations are administered.

Aluminum hydroxide is in some Hep B shots and research has shown that it may affect the blood, bones and liver, all of which are common areas of the body for children’s cancer.

Lymphoma is a cancer of the immune system. Is it simply coincidence that children receive several shots containing carcinogenic chemicals and animal viruses meant to supposedly stimulate their immune systems and then develop cancer of the immune system?

Let’s start with immunologist Charles Janeway. Janeway did a significant amount of research into what he called “the immunologist’s dirty little secret”– that the presence of foreign antigens alone are often not enough to elicit a response from the immune system. In fact, it has been well known amongst immunologists for a long time that the presence of bacteria and viruses is often not enough to induce a response from the immune system. This is why scientists routinely add substances like mineral oil, bovine serum albumin and mineral salts like aluminum hydroxide to their experiments to get a reaction from the immune system.

So while we’ve been told that vaccines work by imitating an infection which then leaves the body with T- and B-lymphoctes which tell it how to fight the infection in the future, it’s not the bacteria or viruses that are causing the immune reaction, it’s the adjuvants.

autoimmune arthritis, amyloidosis, (a condition in which abnormal protein buildup is deposited in an organ of the body) anterior uveitis (inflammation of the eye which can ultimately cause blindness).

Cross reactions with human tissue antigens causing glomurelonephritis (inflammation of the filters in the kidneys) or meningoencephalitis (inflammation of the brian and meninges that can result in speech and motor impairment, epilepsy and intellectual deficits; ironically, vaccination is often recommended as a way to prevent encephalitis and meningoencephalitis.)

Immune suppression (Aren’t vaccines supposed to enhance, the immune system, not compromise it? If they’re suppressing the immune system, then what’s the point?)

Edelman doesn’t care to explicitly state which of these risks are “real” and which are “theoretical”.

CLAIM: It’s not like a parent’s decision not to vaccinate his child harms other kids.

Vaccinated kids generally won’t get sick from the preventable diseases that they’ve been inoculated against. However, if a non-vaccinated kid gets sick with a preventable disease, there are still several people he may infect beyond non-vaccinated classmates.

What do you consider “generally won’t get sick”? Is this what you consider “generally won’t get sick”?

Which one of these examples do you feel fits the description of “generally won’t get sick”?

He may infect babies that haven’t yet been scheduled to receive their vaccines. He may also infect the small percentage of kids for whom their immunizations don’t work, as immunizations aren’t 100 percent effective. The measles vaccine, for example, is more than 95 percent effective—very good, but not perfect.

Well, the CDC tells a very different story than respected vaccinologist Dr. Gregory Poland. To quote the article referenced: “Dr. Poland is no vaccine denier. Not only is he among the harshest and most outspoken critics of the ‘irrationality of the antivaccinationists,’ he is also one of the strongest proponents for vaccines and the good that they can do. As Professor of Medicine and founder and leader of Mayo Clinic’s Vaccine Research Group, one of the world’s largest vaccine research organizations; as editor-in-chief of the peer-reviewed scientific journal, Vaccine; as recipient of numerous awards; as chair of vaccine data monitoring committees for pharmaceutical giant Merck; as patent holder in various vaccines processes; as someone who enjoys special employee status with the Centers for Disease Control and the U.S. Department of Defense and as someone who has sat on every federal committee that has dealt with vaccines, no one can accuse him of seeing vaccines from a narrow perspective.”

Dr. Poland has stated that the MMR shot is not effective at preventing measles on a wide scale. He says that the MMR vaccine is far less effective than anticipated and that immunity from it quickly wanes. To quote again: “During the 1989-1991 U.S. outbreaks, 20 per cent to 40 per cent of those affected had received one to two doses. In a 2011 outbreak in Canada, “over 50 per cent of the 98 individuals had received two doses of measles vaccine… People’s failure to get vaccinated is deplorable, Dr. Poland often stresses. But the more fundamental problem stems from the vaccine being less effective in real life than predicted, with a too-high failure rate — between 2 per cent and 10 per cent don’t develop expected antibodies after receiving the recommended two shots. Because different people have different genetic makeups, the vaccine is simply a dud in many, failing to provide the protection they think they’ve acquired. To make matters worse, even when the vaccine takes, the protection quickly wanes, making it unrealistic to achieve the 95 per cent-plus level of immunity in the general population thought necessary to protect public health. For example, 9 per cent of children having two doses of the vaccine, as public health authorities now recommend, will have lost their immunity after just seven and a half years. As more time passes, more lose their immunity. ‘This leads to a paradoxical situation whereby measles in highly immunized societies occurs primarily among those previously immunized,’ Dr. Poland stated.”

And just like pertussis, vaccinated individuals can contract measles and not present with classical measles symptoms and may not be detected by tests for typical wild measles cases. And this isn’t coming from some “natural news” site, it’s coming from the 2009 Journal of Infectious Diseases. It contains an article about nonclassical measles in two fully vaccinated physicians which can be found here. It discusses a number of aspects of the disease eradication program and the role of vaccination. Little is really known about the full impact of modified/nonclassical measles because it is rarely given any consideration as a diagnosis and remains a little researched subject. “To complicate matters, nonclassic cases of measles in vaccinated persons may be identified, which must be investigated. Often the symptoms are mild and resolve rapidly and, outside of the context of an outbreak or known exposure to a measles case patient, the nonclassic presentation might not raise suspicion of measles.” Also discusses the role of the lack of wild measles virus on the disease: “… the rate of nonclassic infection is likely to increase as measles control improves in a population, because boosting from exposure to wild-type measles virus will be rare. ” (In other words, the wild virus primes the immune system and if eliminated will not be present to “remind” the immune system of what it is supposed to be fighting.) Also discusses difficulties with detecting cases of nonclassical measles in vaccinated individuals because the usual IgM method used for measles diagnosis confirmation is unreliable in nonclassical cases.

Since the publication of that article in 2009, a 2011 outbreak of measles in New York was traced to a woman who was fully vaccinated. So while the media, the healthcare profession and this “science” magazine are implicating non-vaccinated individuals as ignorant specimens of humanity passing around horrendous diseases, we know that fully vaccinated individuals can contract non-typical forms of so-called “vaccine preventable diseases” and pass them on to others. Unfortunately, we don’t know the full public health impact of it because it isn’t being studied widely and most of the time individuals aren’t being tested for these diseases if they are up to date on their vaccines.

Delaying a vaccine just means there’s that much longer a window for an unimmunized child to get sick. Limiting the number of doctor’s visits children need to get all their shots also helps more families stick to the recommended schedule and reduces the costs of vaccination.

“A longer window for an unimmunized child to get sick.” Well let’s talk about long windows for getting sick and the consequences. If you take above cited statistics on the measles, for example, the highest rates of morbidity and mortality are not in children, but adults- which is why developing the measles as a school age child and then having life long immunity could actually be more ideal from a health perspective. We actually do things backwards where we are immunizing school age children and then leaving them open to future infection as adults when the stakes are actually higher. The same actually goes for many other diseases like rubella and chicken pox (pregnancy complications) and mumps (infection to testicles in adolescent boys). A better strategy might actually be to forego vaccinating children for these diseases and vaccinate adults and teens who do not have demonstrated immunity through blood titers test.

How about the flu? What window of time applies to flu vaccination? Recently the flu mist vaccine was found to be almost completely ineffective against influenza after being the recommended choice for children for several years and after several studies from the manufacturer which pointed to it being highly effective. (The manufacturer stands by its studies even though real world observations have proven otherwise, prompting its downgrade from preferred method for children). And even when flu vaccines do work against the strains contained in them, they don’t work against other strains.

And side note: This article claims that vaccines just aren’t profitable for pharmaceutical companies to research and produce. Let’s just take a quick look at that. Bringing up our dear friend Dr. Offit, he wrote an article in 2005 saying that vaccines aren’t profitable and predicting dire consequences from a lack of vaccine development, and in the past eleven years several new vaccines have some how made it into the regular rotation for children, adults of all ages and pregnant women. And while there are plenty of news articles out claiming otherwise, there are other voices from the medical and pharmaceutical fields saying the opposite:

“But the economics of this landscape are changing. The once low-margin vaccine market now includes blockbuster and megablockbuster products. Optimism over new candidates — including some for cancers, human immunodeficiency virus (HIV), and adult influenza — has led to expectations of healthy growth. Economists at the World Health Organization (WHO) report that the market has been growing at 10–15% annually, compared with 5–7% growth for other pharmaceutical segments, since 2000. That growth is expected to continue at 8% or better through 2018, reaching almost US$100 billion by 2025 (2, 3). And some signs indicate that vaccine players may be narrowing their focus to a few areas (e.g., biosimilars) to reduce competition. Thus, an examination of the industry value chains reveals significant bottom-line potential.”- BioProcess International

“One of the new vaccines Gavi is tasked with introducing is the pneumonia vaccine (PCV), which aims to combat a major childhood killer in developing countries. A dramatic 37 per cent (or US$2.8 billion) of the total amount raised for Gavi last week from taxpayers and private foundations will go to pay for just this one high-priced vaccine, which today is produced by only two pharmaceutical giants: GlaxoSmithKline and Pfizer. The two companies have made more than US$19 billion in sales off of the vaccine since its launch, yet still charge developing countries unaffordable and unsustainable prices. It’s important to point out that this vaccine was initially developed for children in wealthy countries, and its research and development costs have long been recovered.” –Stephen Cornish, Executive Director of Doctors Without Borders, Huffington Post Canada

One of my personal favorites though was actress Kristen Bell’s Huffington Post article in which she claimed that vaccines weren’t profitable and used a link to an article in The Atlantic titled “Vaccines Are Profitable. So What?” to support her claim. (Bless her heart, I do believe that Ms. Bell has the best of intentions and cares very much about making the world a better place. And yes, I enjoyed Frozen just as much as the next person.)

Going further into the flu, is it really the flu that kills or other accompanying complications? Take for example NBC’s account of a previously healthy teen athlete who supposedly died from the flu within days with no prior history of health problems. There is something very subtle going on with this article if you take a good look at it. They keep focusing you over and over again on the flu and the flu vaccine, but they mention that the boy had been diagnosed with a MRSA (methicillin resisitant staphylococcus aureus) infection and that he went into organ failure. MRSA is a nasty bacterial infection that can and does cause death by infecting the bloodstream (MRSA sepsis) and organs like the lung and heart. And it often seems like the flu at first. According to the Mayo Clinic, athletes who play contact sports are at an increased risk of contracting MRSA.

So while this boy did have influenza and he did die very suddenly and his family has focused on his story for flu shot awareness, clinically speaking, there is a very good possibility that MRSA contributed substantially to his death- even though the article keeps deflecting the issue. (For another account of a previously healthy teenage boy who contracted MRSA through contact sports and then started experiencing flu-like symptoms, see this article here from the University of Maryland Medical Center. Fortunately, this boy’s condition was found to be MRSA infection in enough time to save him, though he spent 59 days in pediatric intensive care fighting organ failure.) The family’s reaction is completely understandable. They have experienced a living nightmare and are trying to find a way to put their lives together after a tragedy. But unfortunately, there is no flu shot that can protect against MRSA. And for a further investigation into how flu deaths are even being tallied, see my flu post here. So whether you choose to get the flu shot or not, you’re not looking at some sort window of protection.

How about Hepatitis B? Does the window of infection for that one really start at birth for babies whose mothers are negative for the disease? Because statitiscally speaking, the chances of a baby contracting hepatitis B from a low-risk mother are negligible. For a more in-depth explanation of Hepatitis B risks, see my post here.

Beyond that, however, there’s little evidence about which alternative schedules of vaccinations is best and whether alternative schedules are better or worse than the standard schedule. The standard schedule has been studied because the vast majority of U.S. kids get it, but alternative schedules are pretty new and several different alternatives exist, so they are difficult to study. The Institute of Medicine is trying to figure out whether a study of alternative schedules is feasible.

Some delayed schedules celebrities (and celebrity doctors) have endorsed leave out some vaccinations altogether, which leave kids vulnerable to those diseases.

Well it’s not like the APA’s schedule is the gold standard either, for that matter. Many other countries follow different schedules and we don’t label these countries as a whole to be “anti-vaccine”. They all have reasons with research for the type of schedule they employ. And for that matter, adding more vaccines isn’t proof positive of lower childhood mortality either.

You can take a look at vaccine schedules from other countries like Iceland, Singapore, Great Britain and even our neighbor to the north Canada and see that they don’t give as many vaccines as we do. For example, Great Britain does not routinely give a varicella, hepatitis A or rotavirus vaccine, nor does Singapore. Iceland doesn’t routinely give out vaccines for hepatitis A or B, rotavirus, varicella or Human Papilloma Virus. In Canada, the vaccination schedules vary from province to province and in some provinces the rotavirus vaccine is not publicly funded. And guess what? Children are still very healthy in these nations. For a quick measuring stick, let’s take under 1 year infant mortality rates from the CIA fact book: the US ranks 167th for infant mortality, the UK 187th, Singapore is 221st, and Iceland ranks 223rd. (Lower is better, it means there are fewer deaths in a given year per 1,000 live births, e.g. Iceland has 2.06 deaths per 1,000 live births and the US has 5.87 deaths per 1,000 live births. This isn’t a perfect indicator since it includes deaths due to birthing practices. It gives an indicator of the overall state of health of children under 1 year. However, a great many vaccines are administered to children under 1 year because this is when they are supposed to be the most susceptible to many diseases- which is the argument against delayed vaccination schedules.)

CLAIM: Every medicine has side effects, and I want to protect my kids.

It’s always important to know about side effects before deciding to give your kid a vaccine or another medicine.

Most of the side effects of vaccines are mild compared to the illnesses they prevent. Different vaccines may cause temporary fussiness, swelling, prolonged crying and other effects. Some babies get mild vomiting and diarrhea after the DTaP and rotavirus vaccines. (We fully acknowledge that what doctors call “mild vomiting and diarrhea” is not fun to have to take care of.)

Very rarely, kids may be severely allergic to a vaccine. Allergic reactions generally occur within hours of getting a shot. The reaction may be bad enough that a kid can’t get the rest of the shots in that series, which means he or she will have to rely on other kids being vaccinated to protect him from that disease.

1 in 20,000 to 1 in 100,000 babies who get the rotavirus vaccine get a serious bowel blockage for which they have to visit the hospital. Some will need surgery.

This isn’t an exhaustive list of the potential side effects of different vaccines, though I’ve tried to cover the most severe ones. You can find out more from the Centers for Disease Control and Prevention.

Well, we’re in the home stretch here folks. Let’s talk about side effects. We’re used to hearing extravagantly large numbers for vaccine side effects 1 in 4,000,000 and the like. The thing is, these rates are typically based on two variables: the number of doses of vaccines manufactured and the number of incidents reported as vaccine reactions. Let’s talk about the first variable, the number of doses manufactured. Not every dose of vaccine that is manufactured is actually administered. Obviously a vaccine can’t cause a reaction unless it is administered, so counting doses manufactured doesn’t give an accurate picture. In 1980, the Office of Technology Assessment was asked by the House Interstate and Foreign Commerce Committee to put together a memorandum on the possibility of a vaccine injury compensation program. This is a very interesting read and highly informative. The full memorandum can be found here.

From the OTA: “Estimating the number of serious adverse vaccine reactions that occur annually in the United States cannot be accomplished with absolute certainty. There are conflicting incidence estimates for the various adverse reactions, and no one really knows how many doses of vaccine are actually administered (versus distributed) annually, particularly by private physicians. An often-used conservative rule of thumb is to estimte one-fourth wastage.” Current (last updated July 1, 2016) charts from the VICP simply use the number of doses administered between January 1, 2006 and December 31, 2014 simply use the number of doses distributed according to the CDC.

The second variable is how many incidents are actually attributed to vaccine reactions. I think it is entirely possible that there is a bias on the part of physicians. They have heard that vaccine reactions, especially disabling ones or death are so incredibly rare that it is extremely unlikely that they would ever see one. So, I think it is possible that many vaccine reactions are misdiagnosed as other conditions with similar symptoms. For example, encephalitis is a known side effect of live virus vaccines, though the symptoms of disability resulting from encephalitis can be very similar to those of autism. In another example, Guillain-Barre Syndrome could be mistaken for multiple sclerosis. The above cited article on autoimmune encephalitis says that the condition often looks very much like multiple sclerosis.

Underreporting is a possibility. An interesting letter from a New York pediatrician to the British Medical Journal brought up the possibility of underreporting with an example of Kawasaki Disease and Rotateq (which I did not plan): “During the 18-year period from 1990 through 2007 just 88 cases of Kawasaki Disease in children under 5 were reported to VAERS. During the same period about 88 million U.S. children passed through the 0-5 age group; consequently the incidence rate reported to VAERS was 0.10 KD cases per 100,000 person-years. (Pediatr Infect Dis J 28:943, 2009) From 1988 to 2006 the published KD incidence for U.S. children under 5 rose from 11.0 to 20.8 per 100,000 person-years. (Pediatrics 111:448, 2003. Pediatrics 112:495, 2003. Pediatr Infect Dis J 29:483, 2010) Even for infants 3-6 months old, when suspicion for vaccine adverse effects should be especially high, KD incidence as reported to VAERS was 0.11 while published background rates were 23.1 (2000) and 24.6 (2006); fewer than 1 in 200 KD cases were reported to VAERS. It is bewildering, therefore, to learn that FDA and CDC officials used VAERS data to dismiss a placebo-controlled trial that found a 5-fold KD risk associated with RotaTeq–RR=4.9; 95% CI 0.6, 239. (Pediatr Infect Dis J 28:943, 2009. 6/15/07.) If confirmed by a larger trial, the KD risk associated with RotaTeq would translate to an extra 4000 U.S. cases annually in young children.” So there could be misrepresentations with the calculation of vaccine adverse events.

But for a moment let’s take all that off the table and say that the OTA’s estimate in their memorandum is completely accurate. We know that vaccines frequently have a very high failure rate and that herd immunity is more wishful thinking than actual fact. So parents have to decide whether they feel like it is worth the possibility of their child suffering a disabling condition to receive a medical procedure that can’t actually provide high level of protection for themselves or others.